Drug Approval | March 16, 2024
Lupin receives Form 483 with 1 observation from USFDA after inspection at Aurangabad facility
The company is confident of addressing the concern raised by the USFDA
The company is confident of addressing the concern raised by the USFDA
Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders
CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications
It is the first autotaxin inhibitor to be investigated in cancer patients
The company will provide comprehensive response to USFDA for the observations
The inspection was concluded with few procedural observations
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty
This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently
The product will be launched in March 2024
The observations do not pose any risk to site's compliance standards or its business continuity
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